- MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, with >10 years of industrial experience; or PhD in Pharmaceutics, Chemistry, Biophysics or Biochemistry with > 5 years of relevant experience.
- The candidate will have had strong experience in characterization of Biological Drug Products containing proteins, polysaccharides and/or protein conjugate formulations. Experience in characterization of vaccine systems containing adjuvants will be an advantage.
- Experience of testing within GxP environments either directly or through CMOs.
- Strong experience in method development for HPLC (SEC, RP, AEX, HPAEC-PAD) based assays, particle light scattering analysis (DLS, MALS), quantitative subvisible particle analysis (MFI, Laser Diffraction), visible analysis, is required.
- Demonstrated experience in authoring analytical technical documents, including method protocols and SOPs, assay transfer and implementation protocols and reports, validation protocols and reports.
- Participated in method transfers to external vendors and to internal collaborators.
- Strong scientific leadership is required: critical thinking, ability to present complex data sets and to independently propose and design follow-up experiments.
- Managerial experience is of notable benefit.
- The candidate should have high degrees of both flexibility and organizational skills as well as an eagerness and ability to learn to effectively navigate Vaxcyte's multiple projects and timelines.
- Strong interpersonal skills, ability to communicate effectively both verbally and in written formats are necessary to collaborate effectively with the rest of the Drug Product Development team and well as across other teams.
- Detail oriented, rigorous and excellent skills in record keeping.
Reports to: Associate Director, Drug Product Analytics
Location: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $152,000 – $170,000
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Group Leader, Drug Product Analytics - San Carlos, United States - Vaxcyte, Inc.
Description
Join our Mission to Protect HumankindVaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it Our work together is guided by four enduring core values:
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
Summary:
Vaxcyte is looking for an energetic and talented individual to join our Drug Product Analytics team. The candidate must have extensive knowledge and practical experience in analyzing and characterizing Biological Drug Products (proteins, polysaccharide conjugates, vaccines) using HPLC, CE, spectrophotometric techniques, light scattering and particle sizing techniques. Experience in analyzing vaccine and adjuvant containing formulations is a plus.
The responsibilities will be primarily to develop analytical methods, biophysical characterization assays and coordinate routine testing in support of formulation development across all projects in the pipeline in all stages of development. The position will require managing a team of 3-4 scientists.
The candidate will work independently to develop analytical methods, perform analytical data review, authorship of protocols and reports, coordination and oversight during assay transfer with the Vaxcyte QC team and external CMO partner groups.
This will consist of:
· Leading analytical method development and execution for Drug Product characterization.
· Lead (direct management) a team of scientists to support process development activities, formulation selection and stability analysis of Drug Product and/or Intermediate and Drug Substance materials.
· Evaluate and develop the most appropriate biochemical and biophysical characterization tools to support biological drug product development, including adjuvanted vaccine drug products.
· Apply biophysical characterization techniques to fully understand antigen/adjuvant interactions and to assess formulation matrix optimization options.
Vaxcyte is looking for an experienced and flexible individual who would be comfortable working on multiple projects at once, with fluid prioritization to enable aggressive timelines. This position is for a scientific role which will be partly lab based, whilst requiring excellent scientific judgement, independence, rigor and thorough record keeping.
Requirements:
